ARTICLE
13 November 2015

Inductos To Remain Suspended In EU, Pending Resolution Of Manufacturing Issues

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On October 23, 2015, the CHMP has recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures.
European Union Food, Drugs, Healthcare, Life Sciences

On October 23, 2015, the CHMP has recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures. EMA started a review of Inductos following an inspection by Dutch and Spanish authorities, which found the production site of the absorbable sponge to be noncompliant with manufacturing requirements. Specifically, the inspectors noted that the manufacturer, located in the United States, did not have adequate measures in place to prevent particle contamination of the sponges. Hence, the CHMP concluded that Inductos should be suspended until the manufacturing issues are satisfactorily addressed.

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